Last updated on January 2019

Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer


Brief description of study

This is prospective cohort study, in pregnant women who present with signs and symptoms of possible deep vein thrombosis. All patients will have the same method of assessment of their deep vein thrombosis (DVT) symptoms (the LEFt clinical decision rule will be applied and D-dimer test will be done) to determine if a compression ultrasound is required. All patients will be followed for a period of 3 months.

Detailed Study Description

VTE is a leading cause of maternal death in the developed world. Suspected DVT in pregnancy is a common clinical problem faced by clinicians daily. The only validated method to exclude DVT in pregnancy requires leg vein CUS imaging. This imaging modality is costly and has limited availability (only available in radiology departments and, usually, only during weekday daytime hours) often necessitating referral to the emergency room for initiation of heparin injections until leg vein CUS can be obtained. A simple and seemingly powerful clinical decision rule (LEFt) and a simple blood test (D-dimer) may be promising to exclude DVT in pregnancy without the need for diagnostic imaging. Validating the safety of a simple, non-invasive, widely available approach to suspected DVT in pregnancy would be an important advance in maternal health.

A prospective cohort diagnostic management study in pregnant women with suspected DVT, with three-month follow-up for symptomatic VTE will take place in multiple centres in Canada.

After obtaining informed consent, all patient will have the LEFt clinical decision rule applied by the attending physician and will have D-Dimer testing (D-Dimer results of test performed within 24 hours will be accepted and do not need to be repeated).

Patients with an "unlikely" LEFt score of 0 or 1 point and a negative D-dimer will not undergo diagnostic imaging.

Patients with either a "likely" LEFt score of 2 or 3 points or a positive D-dimer will undergo either a single complete leg vein compression ultrasound (CCUS) (Day 1) or a serial proximal leg vein (CUS) (Day 1 and Day 7).

All patients will be followed for 3 months for symptomatic VTE.

Clinical Study Identifier: NCT02507180

Contact Investigators or Research Sites near you

Start Over

Scott Stevens, MD

Intermountain Healthcare, Inc.
Murray, UT United States
  Connect »

Paul Gibson, MD

Foothills Medical Centre
Calgary, AB Canada
  Connect »

Rshmi Khurana, MD

Royal Alexandra Hospital
Edmonton, AB Canada
  Connect »

Wee-Shian Chan, MD

Children's and Women's Health Centre of British Columbia
Vancouver, BC Canada
  Connect »

Sudeep Shivakumar, MD

Queen Elizabeth II Health Science Centre
Halifax, NS Canada
  Connect »

Shannon Bates, MD

Hamilton Health Sciences Centre
Hamilton, ON Canada
  Connect »

Michael Kovacs, MD

London Health Sciences Centre
London, ON Canada
  Connect »

Marc Rodger, MD

Ottawa Hospital Research Institute
Ottawa, ON Canada
  Connect »

Anne McLeod, MD

Sunnybrook Medical Hospital
Toronto, ON Canada
  Connect »

Kahn Susan, MD

Jewish General Hospital
Montreal, QC Canada
  Connect »

Marc Righini, MD

Hopitaux Universitaires de Geneve
Geneva, Switzerland
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.